DENTSPLY LLC

FDA Device Registration & Listing · York, PA, US · Registration 2424472

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2424472
FEI Number
3002088145
Entity Name
DENTSPLY LLC
City/State/Country
York, PA, US
Establishment Address
1301 SMILE WAY, York, PA 17404, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K842392
PMA Number
N/A

All Registered Proprietary Names

Shorty Handpiece & Motor, Midwest Handpiece, Contra Angle Heads Straight Attachments Rhino Handpiece Midwest RDH SofScale XCP-DS® Sensor Holder X-Ray Exposure Alignment (XCP® / XCP-ORA®) Uni-GRIPAR® Universal Body Stain Universal Stain Celtra Ceram Universal Incisal Stain Dentsply Sirona Universal Overglaze CELTRA Duo Dentsply Sirona Universal Incisal Stain Dentsply Sirona Universal Body Stain Universal Overglaze-High Flu Dentsply Sirona Universal Stain & Overglaze Kit Dentsply Sirona Universal Stain Dentsply Sirona Universal Overglaze-High Flu Universal Overglaze Snap-A-Ray® Film Holder Uni-Grip® Universal Radiography Holder BAI Bite-Block film holders Rinn Digital Sensor Covers Flip-Ray XCP-DS FIT® Sensor Holder Rinn® Digital Sensor Loops XCP-DS® Digital Sensor Replacement Baskets and Bite Blocks XCP-DS® Replacement Bitepieces Uni-Grip® 360 Universal Sensor Holder Eezee-Grip® Digital Sensor Holder Silicone BW #2 Film Holder EndoRay® II Endodontic Film Holder Snap-A-Ray® DS for Sensors XCP® / XCP-ORA® Film Positioning Kits Adhesive Comfort Tab for Film -Cover Cozee® BAI Instrument Kits Bite-Wing Loops film holders Bite-Wing Instrument Kits RINN® XCP-ORA® Cover Cozee Sensor Cover Tamer XCP® Disposable Bite-Blocks (film holders) Bite-Wing Bite-Blocks film holders Uni-Bite® Universal Film Holder Cover Cozee Comfort Solution XCP-DS® Digital Sensor Positioning Kits Rinn® Loops Schick CDR Elite Sensor Holder Cover Cozee BW Rinn® Cover-Cozee® Sensor Cover Tamer Stabe® Disposable Film Holders Adhesive Bite-Wing Tabs XCP®, BAI & XCP-DS® Stainless Steel Indicator Arms Ceramco 3 Enamel, Excelsior Porcelain, Delton Pit & Fissure Sealant, Sporox II Cerec Camera Care Kit RINN XCP-DS FIT Genios Teeth Ceramco 3 C3 SofTip Dispos Prophy Tip Bobcat PRO Ultrasonic Scaler, Inserts, EZ Auto Light Flatscreen Viewer Universal Countertop/Wall Mount Film Viewers Jenker Needle Stick Protector NUPRO Sensodyne Prophylaxis Paste with NovaMin Colorlogic Edge Shoulder Ceramco I Cermaco II Ceramco 3 JET-Fresh Prophy Powder FLASHTIPS Delton Clear Pit & Fissure Delton FS+ Lucitone Digital Print Delton PLUS Aquasil Ultra Cordless digit Power Dispenser digit Syringe Dispenser Prophy Jet Air Polishing System, JetShield Assembly, Inserts, Prophy Jet Sheath Delton Opaque Pit & Fissure Sealant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2008-02-18
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
EAP Unit, X-Ray, Intraoral Dental Class 2 872.1810 2018-10-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-10-31
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
EIH Powder, Porcelain Dental Class 2 872.6660 2012-11-30
EHA Aligner, Beam, X-Ray Dental Class 1 872.1820 2008-02-19
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2016-06-17
EIH Powder, Porcelain Dental Class 2 872.6660 2016-08-16
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 1996-05-01
EIH Powder, Porcelain Dental Class 2 872.6660 2008-02-19
IZX Collimator, Manual, Radiographic Radiology Class 2 892.1610 2016-08-11
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-06
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2008-04-16
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2018-06-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-07-25
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2008-04-16
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2008-04-16
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2016-09-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-04-05
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2015-06-16
EAP Unit, X-Ray, Intraoral Dental Class 2 872.1810 2018-10-31
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1997-06-27
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2019-09-05
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-09-05
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2019-09-05
EIH Powder, Porcelain Dental Class 2 872.6660 2008-02-28
EFT Cleanser, Denture, Over The Counter Dental Class 1 872.3520 2005-12-28
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2009-11-13
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
IXC Illuminator, Radiographic-Film Radiology Class 1 892.1890 1996-05-01
DZM Needle, Dental Dental Class 1 872.4730 2008-03-06
EKQ Preparer, Root Canal Endodontic Dental Class 1 872.4565 1977-12-28
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-16
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2012-08-09
EIH Powder, Porcelain Dental Class 2 872.6660 2008-02-20
KOJ Airbrush Dental Class 2 872.6080 2008-03-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2006-03-16
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-06
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-06
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2019-05-23
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-06
LBH Varnish, Cavity Dental Class 2 872.3260 2012-10-16
OYH Orthodontic Vibratory Accessory Dental Class 2 872.5470 2021-02-12
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 1979-02-20
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-03-06
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2424472. Last updated year: 2026. Please use registration number 2424472 when referencing this establishment in official correspondence.
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